Intraurethral magnetic valve and associated parts

Abstract

To solve the problem that a system for placement of intraurethral valves is relatively complex, and the simplification of the system is generally desired.SOLUTION: An intraurethral magnetic valve having an inlet port 112 and an outlet port 25 is provided, the valve including: a valve main body 11; a ferromagnetic ring 5 located at least partially within the valve main body 11; a valve seat 4; and a magnetic valve element 14 located within an internal volume 111a defined by the valve main body and configured to move with respect to the ferromagnetic ring 5, that movement being within the valve main body 11 between a closed configuration in which fluid is inhibited from flowing from the inlet port 112 through the outlet port 25 and an open configuration in which fluid is permitted to flow from the inlet port 112 through the outlet port 25, movement of the magnetic valve element 14 being on exposure to a magnetic field from an external magnet member, wherein the valve seat 4 is formed from an elastomer material.SELECTED DRAWING: Figure 3a

Description

[Technical field]

[0001] Description of the invention Embodiments relate to intraurethral valves and valve systems, systems for placement and / or removal of intraurethral valve systems, and the like. [Background technology]

[0002] It is generally desirable to provide an intraurethral valve that can selectively control the flow of fluid therethrough. Such a valve may be required, for example, in connection with patients suffering from urinary retention insufficiency.

[0003] An example of the placement of such a valve in a male patient can be seen in Figure 1, which is an excerpt from Figure 3 of US Patent No. 6,066,088. Reference numbers specifically referring only to the prior art figures (Figures 1 and 2) herein are provided in parentheses (to aid in understanding, similar reference numbers are used (without parentheses) to refer to the embodiments where appropriate).

[0004] As can be seen, Figure 1 shows a cross-section of a human male abdomen (30). The valve (1) may be positioned within the patient's bulbar urethra (26), generally at the bulge (17) and generally upstream of the pendular urethra (27) in terms of the normal flow of fluid through the urethra. The valve (1) is coupled to a retention mechanism by a catheter that defines a lumen (21) as the outlet of the valve (1) and an inlet defined by the retention mechanism. The retention mechanism is positioned in the bladder (29) and includes a retention loop (28) that holds the retention mechanism in place relative to the bladder neck (22).

[0005] Thus, movement of the valve (1) between the open and closed configurations is intended to control the flow of fluid from the bladder (29) through the outlet (25) to the pendular urethra 27.

[0006] Important advances in this regard include the intraurethral magnetic valve of WO 00 / 02499. For ease of reference, FIG. 1 of this document is repeated as FIG. 2 of the present application. This document teaches an intraurethral magnetic valve (1) for insertion into the human urethra of a person suffering from incontinence. The intraurethral magnetic valve (1) includes a non-ferromagnetic cylindrical housing (2), a valve seat assembly (36) attached to one end of the housing, a spherical magnetic valve element (14) arranged for free movement within the housing, and a ring (10) for retaining the valve element, attached to the other end of the housing. The valve seat assembly (36) has a non-ferromagnetic valve seat (4) and a ferromagnetic ring (5). The valve element (14) is maintained in a closed, shut-off position against the valve seat (4) by the force of attraction to the ferromagnetic ring (5), restricting the flow of fluid through the valve (1). An external magnet is used to apply a magnetic torque and attractive force to the valve element (14) to move it away from the valve seat (4) and open the valve for fluid flow. When the external magnet is removed, the valve element (14) returns to the closed shutoff position on the valve seat (4). This document also teaches a second embodiment in which the intraurethral magnetic valve (1) includes a mechanism with a spring for relieving excess fluid pressure, where the valve seat assembly (36) is not attached to the housing (2) but is axially slidable within the housing against the force of the spring when excess hydrostatic pressure is present, allowing fluid to be expelled through a passageway around the valve seat assembly (36).

[0007] Such advanced intraurethral magnetic valves seek to allow selective release of fluid from the bladder through the use of an external magnet; in other words, a magnet external to the patient's body can be brought into proximity with internally mounted intraurethral magnetic valves to actuate them from an open to a closed configuration.

[0008] However, even these intraurethral magnetic valves have challenges. For example, the valves can exhibit a poor seal around the valve between the outer portion of the valve and the urethral wall. A poor seal in this area can allow fluid to leak around the valve, especially when the fluid pressure is relatively high, although the valve can operate correctly unless actuated into an open configuration and prevent fluid flow through the valve. Similarly, there are challenges in maintaining a good seal between the valve element and the valve seat, especially over the life of the valve.

[0009] The environment in which the valve and its retention mechanism are placed may result in the attachment of mineralized biofilms of, for example, Proteus mirabilis or other microbial material, which may result in clogging of the valve or affect the seal between the valve and the urethral wall (which may lead to leakage, as discussed above).

[0010] The placement of intraurethral valves has also been the subject of development. In particular, a system for placing an intraurethral valve must be capable of pushing the valve and associated retention mechanism through the urethra into a desired position. However, during placement of the valve in this manner, it is not uncommon that pulling and twisting of the valve and its retention mechanism is required for accurate placement and guidance through the urethra. Typically, such placement systems require a portion that is operated by a practitioner (e.g., a surgeon or other medically qualified person) and therefore does not enter the patient's urethra. All or part of this portion of the placement system must be capable of being detached from the valve and its retention mechanism after placement of the valve. Thus, a placement system for an intraurethral valve must be capable of guiding the valve and its retention mechanism through the urethra into a desired position and at least partially detachable following its placement.

[0011] One such example is WO 2008 / 067557, which teaches a system for implanting a catheter in the urethra. The system includes a catheter having a magnetic intraurethral valve disposed at one end of the catheter. The system also includes a tool having a tip member that extends into an opening at a first end of the catheter and couples the tool to the catheter. The system also includes an element extending from the tool. The catheter has an internal passageway that extends through the valve and provides a conduit for the element to engage the second end of the catheter. The tool is adapted to use the element to apply pressure to the catheter along its length to stiffen the catheter. The stiffening of the catheter facilitates implantation of the catheter in the urethra by allowing pulling, pushing and twisting forces.

[0012] Advances in the field of intraurethral valve placement can also be found in WO 2011 / 032150. This document teaches an insertion facilitation device for facilitating the insertion of a tubular structure into a mammalian body passageway. The device comprises: (a) an elongated reinforcement having a proximal end portion and a distal end portion, the reinforcement being adapted to extend within the lumen of the tubular structure from its distal end portion to its proximal end portion, with the distal end portion of the reinforcement being at least partially within the distal end portion of the tubular structure and the proximal end portion of the reinforcement being at least partially within the proximal end portion of the tubular structure, and to provide the tubular structure with greater stiffness with the reinforcement than without the reinforcement, and adapted to be moved axially within the tubular structure relative to the tubular structure; and (b) an engagement device, in its engaged state, adapted to engage the tubular structure from the distal end portion to the proximal end portion of the reinforcement, with the proximal end portion of the reinforcement being at least partially within the proximal end portion of the tubular structure, the elongated reinforcement being adapted to extend within the lumen of the tubular structure from the distal end portion to the proximal end portion of the reinforcement, and to provide the tubular structure with greater stiffness with the reinforcement than without the reinforcement, the engagement device being adapted to be moved axially within the tubular structure relative to the tubular structure; and an engagement device, wherein the stiffener extends within the lumen of the tubular structure, releasably engaging the stiffener with the tubular structure so that either or both of axial and radial movement of the stiffener relative to the tubular structure during insertion of the tubular structure into a body passageway, and in its disengaged state, disengaging the stiffener from the tubular structure so that the stiffener is at least axially movable through the lumen of the tubular structure and can be withdrawn from the tubular structure, with at least a proximal end portion of the stiffener adapted to be within or adjacent the distal end of the tubular structure. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] U.S. Patent No. 6,066,088 [Patent Document 2] International Publication No. 00 / 02499 [Patent Document 3] International Publication No. 2008 / 067557 [Patent Document 4] International Publication No. 2011 / 032150 Summary of the Invention [Problem to be solved by the invention]

[0014] These systems for placing intraurethral valves, as can be seen from the above documents, are relatively complex and there is a general desire to simplify these systems.

[0015] It would also be desirable to provide a mechanism for extracting the valve and its retention mechanism after placement, which may be required, for example, to allow for periodic replacement of the valve and / or to allow for the attachment of a conventional urinary catheter (e.g., in the case of patients hospitalized for surgery, drug delivery, etc.).

[0016] Advances in intraurethral valves have been focused on use in male patients, in part because of the longer urethra and therefore the greater space available for placement of such valves, however, there is also a demand for such valves in female patients.

[0017] As will be appreciated, placement of the valve in the urethra of a patient (male or female) can be uncomfortable. The valve, due to the need to form a seal, presses against the walls of the urethra - see, for example, FIG. 1. Furthermore, external forces can increase the discomfort. For example, when the patient sits, walks, runs, or climbs stairs, then there may be additional and / or different forces acting on the valve and / or retention mechanism. Changes in these forces may change the pressure on the urethral walls and surrounding tissues by the valve and / or retention mechanism. This may increase the discomfort felt by the patient (indeed, the patient may only feel discomfort when performing some activities, for example, especially when sitting).

[0018] There is therefore a need to improve the overall comfort of such valves when in use. [Means for solving the problem]

[0019] SUMMARY OF THE DISCLOSURE The embodiments seek to alleviate one or more problems associated with the prior art.

[0020] Accordingly, one aspect provides an intraurethral magnetic valve having an inlet port and an outlet port, the valve including: a valve body; a ferromagnetic ring at least partially disposed within the valve body; a valve seat; and a magnetic valve element disposed within an interior volume defined by the valve body and configured to move relative to the ferromagnetic ring, the movement within the valve body between a closed configuration that prevents fluid from flowing from the inlet port through the outlet port and an open configuration that allows fluid to flow from the inlet port through the outlet port, the movement of the magnetic valve element being exposed to a magnetic field from an external magnetic member, and the valve seat being formed from an elastomeric material.

[0021] The elastomeric material of the valve body may form a valve seat, with the magnetic valve element configured to engage the valve seat when in the closed configuration. The valve may further include a valve seat member defining the valve seat and attached to the valve body. The valve seat member may be at least partially received by the valve body. The ferromagnetic ring may at least partially surround a portion of the valve seat member. The valve seat member may be formed exclusively from one or more elastomeric materials. The ferromagnetic ring may be embedded in the elastomeric material forming the valve seat. The magnetic valve element may be configured to adopt an open pass-through configuration in which a passage for the expandable member is provided through the valve. The interior valve volume may include a bulbous portion configured to receive at least a portion of the magnetic valve element when in the open pass-through configuration. The valve seat may be an offset valve seat such that the outlet is offset from a central longitudinal axis of the interior volume defined by the valve body. The valve body may be elastically deformable to reduce a width of the interior volume. The valve may further include one or more external ribs for engaging the urethral wall. The valve may further include an external seal member configured to surround at least a portion of the valve body to assist in providing a seal between the valve and the urethral wall. The external seal member may include a foam material. The external seal member may include an antibacterial and / or antifungal agent. Only the magnetic valve member and the ferromagnetic ring may not be elastically deformable. The valve seat may at least partially receive the magnetic valve element. At least 10% of the magnetic valve element may be received in the valve seat. Less than 50% of the magnetic valve element may be received in the valve seat. The valve body may be tapered towards the outlet port.

[0022] Yet another aspect provides a valve system including a valve as described above, a catheter coupled to an inlet port of the valve, and a retention mechanism coupled to the catheter, the retention mechanism configured to be deployed within the bladder.

[0023] The valve system may further include: an expandable element extending through the valve and catheter and secured to at least a portion of the retention mechanism; and a retention clip configured to engage the expandable element and prevent its movement through the catheter. The valve system may further include an external retention mechanism configured to prevent movement of the valve system into the bladder. The external retention mechanism may include an adjustable retention ring or a foam pad. The valve system may further include one or more external seal members disposed adjacent to the external retention mechanism. A second catheter may couple the external retention mechanism to the valve. The valve system may further include one or more tethers for use in extraction of the valve system.

[0024] Yet another aspect provides a valve system as described above in combination with an insertion tool for use in implanting the valve system, the insertion tool including a sleeve member configured to receive at least a portion of the valve system.

[0025] The sleeve member may be stiffer than the valve system. The valve system may further include an expandable external seal member. The valve system may further include one or more external seal members configured to attach to the catheter and / or valve after implantation, each such external seal member including an annular member configured to be slid along the length of the catheter and / or valve. The valve system may further include at least one internal seal member configured to be received by at least a portion of the catheter such that ribs are formed on the outer surface of the catheter. The valve system may further include a sleeve member extending along at least a portion of the length of the catheter and / or valve, the sleeve member defining one or more holes therethrough and / or including one or more regions formed of a different material than another portion of the sleeve member and / or having a different texture than another portion of the sleeve member.

[0026] Yet another aspect provides a valve system in combination with an insertion and / or extraction tool for use in implanting and / or extracting the valve system, the insertion and / or extraction tool including an engagement member that engages the valve system, the engagement member including at least one of a threaded engagement member, a magnetic engagement member, a hook, a hinged hook, a deployable retention member, and a loop configured to fit around at least a portion of the valve system.

[0027] The valve system may be for use in a male or female human patient. The valve system may be configured for sterile storage with the retention mechanism in a non-deployed configuration.

[0028] Yet another aspect provides an intraurethral valve system including: an intraurethral valve for selective flow of fluid therethrough; a retention mechanism for securing the valve system in place; a catheter coupled between the intraurethral valve and the retention mechanism to enable movement of fluid to the intraurethral valve; an expandable element for use in inserting the intraurethral valve system, coupled to the retention mechanism and passing through at least a portion of the catheter; and a retaining clip configured to engage the expandable element and prevent movement through the catheter.

[0029] The retaining clip may include first and second elongate members joined by a hinge and configured to move about the hinge relative to one another between an open configuration and a closed configuration, and an engagement mechanism for retaining the engagement of the first and second elongate members in the closed configuration. The retaining clip may include two elongate members joined in a U-shaped configuration and defining a slit therebetween for receiving the expandable member. The length of the retaining clip may be greater than the width of the lumen of the catheter. The valve system may be for use with a male human patient or a female human patient. The valve system may be configured for sterile storage with the retention mechanism in a non-deployed configuration.

[0030] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 shows a diagram excerpted from WO 00 / 02499. [Diagram 2] FIG. 2 shows a diagram excerpted from US Pat. No. 6,066,088 (Patent Document 1). [Figure 3a] FIG. 3a shows an embodiment of a valve. [Figure 3b] Figure 3b shows yet another embodiment of the valve. [Figure 4a] FIG. 4a shows an embodiment of the valve in a closed configuration. [Figure 4b] FIG. 4b shows an embodiment of the valve in an open through configuration. [Figure 4c] FIG. 4c shows an embodiment of the valve in an open configuration. [Diagram 5] FIG. 5 shows an end view of the ferromagnetic ring. [Figure 6] FIG. 6 shows a side view of a ferromagnetic ring. [Figure 7a] FIG. 7a shows various external seal member positions and configurations. [Figure 7b] FIG. 7b shows various external seal member positions and configurations. [Figure 7c] FIG. 7c shows various external seal member positions and configurations. [Figure 7d] FIG. 7d shows various external seal member positions and configurations. [Figure 8] FIG. 8 illustrates a retaining clip of some embodiments coupled to a portion of a valve system. [Figure 9a] FIG. 9a shows the retaining clip in an open configuration. [Figure 9b] FIG. 9b shows the retaining clip in a partially closed configuration. [Figure 9c] FIG. 9c shows the retaining clip in a closed configuration. [Figure 10] FIG. 10 shows an embodiment comprising a tether. [Figure 11] FIG. 11 shows the valve system (without the valve) in combination with the insertion tool of some embodiments. [Figure 12a] FIG. 12a shows a valve system (with various valve positions) in combination with an insertion tool of some embodiments. [Figure 12b] FIG. 12b shows a valve system (with various valve positions) in combination with an insertion tool of some embodiments. [Figure 12c] FIG. 12c shows a valve system (with various valve positions) in combination with an insertion tool of some embodiments. [Figure 13] FIG. 13 shows a schematic representation of the magnetic member and the valve. [Figure 14] FIG. 14 shows an expandable member along with a valve system. [Figure 15] FIG. 15 illustrates an exemplary outer seal member. [Figure 16] FIG. 16 illustrates an exemplary set of external seal members. [Figure 17] FIG. 17 shows an example of using an internal member to create an external rib-like projection. [Figure 18] FIG. 18 illustrates a sleeve member according to some embodiments. [Figure 19] FIG. 19 shows a valve with a tapered end, according to some embodiments. [Figure 20a] FIG. 20a illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20b] FIG. 20b illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20c] FIG. 20c illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20d] FIG. 20d illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20e]FIG. 20e illustrates an exemplary extraction and / or insertion tool of some embodiments. [Fig. 20f] FIG. 20f illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20g] FIG. 20g illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20h] FIG. 20h illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20i] FIG. 20i illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20j] FIG. 20j illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20k] FIG. 20k illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 20l] FIG. 20l illustrates an exemplary extraction and / or insertion tool of some embodiments. [Figure 21a] FIG. 21a illustrates a valve system of some embodiments. [Figure 21b] FIG. 21b illustrates a valve system of some embodiments. [Figure 21c] FIG. 21c illustrates a valve system of some embodiments. [Figure 21d] FIG. 21d illustrates the valve system of some embodiments. [Figure 22a] FIG. 22a shows different views of the valve system of some embodiments (such as the embodiment of FIGS. 21a-21d). [Figure 22b] FIG. 22b shows a different view of the valve system of some embodiments (such as the embodiment of FIGS. 21a-21d). [Figure 23a] FIG. 23a shows the valve system partially cut away to depict the open and closed configurations of the valve. [Figure 23b] FIG. 23b shows the valve system partially cut away to depict the open and closed configurations of the valve. [Figure 24a] FIG. 24a shows an embodiment of a valve. [Figure 24b] FIG. 24b shows an embodiment of a valve. [Figure 24c] FIG. 24c shows an embodiment of a valve. [Fig. 24d] FIG. 24d shows an embodiment of a valve. [Figure 25a] Figure 25a shows a different view of the embodiment of Figures 24a-24b. [Figure 25b] Figure 25b shows a different view of the embodiment of Figures 24a-24b. [Figure 26] FIG. 26 shows details of the valve components of some embodiments. [Figure 27a] FIG. 27a shows an embodiment of a valve. [Figure 27b] FIG. 27b shows an embodiment of a valve. [Figure 27c] FIG. 27c shows an embodiment of a valve. [Fig. 27d] FIG. 27d shows an embodiment of a valve. [Figure 28a] Figure 28a shows a different view of the embodiment of Figures 27a-27b. [Figure 28b] Figure 28b shows a different view of the embodiment of Figures 27a-27b. [Figure 29a] FIG. 29a shows an embodiment of the valve system. [Figure 29b] FIG. 29b shows an embodiment of the valve system. [Figure 29c] FIG. 29c shows an embodiment of the valve system. [Figure 29d] FIG. 29d shows details of the valve of FIGS. 29a-29c and several other embodiments. [Figure 30a] FIG. 30a shows the valve system of one embodiment. [Figure 30b] FIG. 30b shows an embodiment of the valve system. [Figure 30c] FIG. 30c shows details of the valve of FIG. 30a and several other embodiments. [Figure 30d] FIG. 30c shows details of the valve of FIG. 30b and several other embodiments. [Figure 31a] FIG. 31a illustrates a valve seat member according to some embodiments. [Figure 31b] FIG. 31b illustrates a valve seat member according to some embodiments. [Fig. 31c] FIG. 31c illustrates a valve seat member according to some embodiments. [Fig. 31d] FIG. 31d illustrates a valve seat member according to some embodiments. [Figure 31e] FIG. 31e illustrates a valve seat member according to some embodiments. [Fig. 31f] FIG. 31f illustrates a valve seat member according to some embodiments. [Figure 32a] FIG. 32a shows parts of the valve of some embodiments. [Figure 32b] FIG. 32b shows parts of the valve of some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] The embodiment may include a valve 1 - see Figures 3 to 6. The valve 1 may be a magnetically actuated valve 1 for placement within the urethra. Thus, the valve 1 may be an intra-urethral magnetic valve 1.

[0033] 3a and 3b, by way of example, valve 1 may include a valve body 11 defining an interior valve volume 111 within which a spherical magnetic valve element 14 (hereinafter, "valve element 14") is disposed. The interior valve volume 111 has a length along a longitudinal axis of the valve body 11. The longitudinal axis of the valve body 11 extends from an inlet port 112 of the valve 1 to an outlet port 25 of the valve 1. The interior valve volume 111 has a width along an axis perpendicular to the longitudinal axis of the valve body 11.

[0034] In some embodiments, the interior valve volume 111 may be generally cylindrical in shape and its width may be, for example, a diameter. In some embodiments, the interior valve volume 111 may generally narrow from its end adjacent the outlet port 25 to its end adjacent the inlet port 112. In some embodiments, there may be a bulbous portion 111a of the interior volume 111, which may face the outlet port 25. The bulbous portion 111a may be a portion of the interior volume 111, which may be wider than at least a portion of the remainder of the interior volume 111.

[0035] Both the inlet port 112 and the outlet port 25 may have a width (eg, diameter) that is smaller than the width of the internal valve volume 111 .

[0036] The internal valve volume 111 is dimensioned to receive the valve element 14, for example, as shown in Figure 3. The internal valve volume 111 can be dimensioned to allow movement of the valve element 14 between closed and open configurations, as described herein.

[0037] Towards the outlet 25 there is a ferromagnetic ring 5. The ferromagnetic ring 5 defines a passageway through which fluid may pass. The ferromagnetic ring 5 is shown in the valve 1 in Figures 3a and 3b as well as shown separately in Figures 5 and 6, for example.

[0038] The ferromagnetic ring 5 may be a continuous ring of ferromagnetic material, as shown in Figures 5 and 6. Figure 5 shows an end view of the ferromagnetic ring 5, and Figure 6 shows a side view. Thus, the ferromagnetic ring 5 may be generally tubular in shape. In some embodiments, the ferromagnetic ring 5 may be ring-like in that the ferromagnetic material may not form a complete ring, but may form a ring-like structure formed from multiple portions of ferromagnetic material.

[0039] The ferromagnetic ring 5 may have a first end facing towards the internal volume 111 when in the valve 1 and a second end that is away from the internal volume 111 (compared to the first end) when in the valve 1. The first and second ends of the ferromagnetic ring 5 may be positioned opposite each other across a length of the ferromagnetic ring 5 (a length that may be parallel to a longitudinal axis of the valve 1 when the ferromagnetic ring 5 is positioned in the valve 1).

[0040] In some embodiments, the first end of the ferromagnetic ring 5 may have a generally flat and / or smooth end surface (which, as will be appreciated, may be an annular surface).

[0041] The ferromagnetic ring 5 may have an intermediate portion extending from the first end toward the second end, which has a generally constant outer radius, and may additionally or alternatively have a generally constant inner radius.

[0042] In some embodiments, the second end of the ferromagnetic ring 5 may include a stepped portion that may include a portion with an outer radius and / or an inner radius that decreases toward the end face of the second end, in some embodiments, the stepped portion extends from the central portion to the end face of the second end of the ferromagnetic ring 5.

[0043] In some embodiments, the ferromagnetic ring 5 has a substantially uniform inner and / or outer diameter along its entire length.

[0044] The ferromagnetic ring 5 may be coupled to the valve body 11, which may be achieved in a number of different ways.

[0045] In some embodiments, the valve body 11 may be formed from, and may be formed exclusively from, an elastomeric material. The elastomeric material may be selected for its biocompatibility and / or the ability to impregnate the material with antibacterial and / or antifungal agents. The ferromagnetic ring 5 may be formed from an iron-based metal or an iron-based metal alloy. Thus, the valve body 11 may be formed from a relatively flexible material compared to the ferromagnetic ring 5. In some embodiments, application of a force to the valve body 11 may cause the valve body 11 to elastically deform, decreasing the internal valve volume width (direction of force). In other words, the body 11 may be resilient to crushing forces to which it may be exposed.

[0046] In some embodiments, the ferromagnetic ring 5 may be embedded in at least a portion of the valve body 11, with the valve body 11 being at least partially formed around the ferromagnetic ring 5. In such embodiments, the formation of the valve body 11 (or at least the portion in which the ferromagnetic ring 5 is embedded) may be a molding process around the ferromagnetic ring 5, and thus the ferromagnetic ring 5 may be placed inside a mold before the elastomeric material for the valve body 11 (or portion thereof) is provided to (e.g., injected into) the mold.

[0047] In some embodiments, the ferromagnetic ring 5 may be secured within the valve body 11 by an interference fit. In such embodiments, the valve body 11 may be formed separately from the ferromagnetic ring 5 or may have a recess defined by the valve body 11 for receipt of the ferromagnetic ring 5. The ferromagnetic ring 5 may then be inserted into the recess and held in place, for example, by an interference fit between one or more surfaces of the valve body 11 and the ferromagnetic ring 5. In some embodiments, a plug of material (which may be an elastomeric material such as may be used for the valve body 11) may be used to secure or help secure the ferromagnetic ring 5 in place. This plug may be positioned towards, and may in fact define, the outlet port 25 of the valve 1 - the plug may, for example, be annular in form with the outlet port 25 defined by the plug.

[0048] In some embodiments, the ferromagnetic ring 5 may be attached to a spigot member of the valve body 11. The spigot member may define a passage therethrough, and the ferromagnetic ring 5 may be slid over the spigot member into position. A plug of material may then be attached over the ferromagnetic ring 5. The plug of material may be generally annular in shape.

[0049] In some embodiments, an adhesive may be used to secure or help secure the ferromagnetic ring 5 to the valve body 11. It will be appreciated that in some embodiments the spigot member may be part of the valve body 11, as well as a plug of material may form part of the valve body 11.

[0050] In some embodiments, the valve body 11 may be of tubular form having one open end and a ferromagnetic ring 5 disposed at the opposite end (which defines an outlet 25 generally having a smaller width than the open end). The open end may be configured to be attached to another portion of the valve body 11 and / or an end of the catheter 16 - the other portion defining the inlet port 112, or an outlet of the catheter 16 forming the inlet port for the valve 1. Thus, the valve element 14 may be disposed within the valve body 11 through its open end before being coupled to another portion of the body 11 and / or an end of the catheter 16 (which other portion of the body 11 may be coupleable to the catheter 16). The catheter 16 may be integrally formed with at least a portion of the valve 1 (such as the body 11) or may be bonded thereto or connected using an adhesive process (such as insert molding).

[0051] In some embodiments in which the valve body 11 is not molded around the ferromagnetic ring 5 during manufacture, the valve element 14 may be inserted through the outlet port 25 (or the end of the valve body 11 where the outlet port 25 will be located) prior to insertion of the ferromagnetic ring 5 (and, e.g., a plug). The elastomeric material of the valve body 11 may be configured, for example, to elastically deform to allow insertion of the valve element 14 in this manner.

[0052] Valve 1 includes a valve seat 4, which may be, for example, a non-ferromagnetic valve seat 4. The valve seat 4 may be formed in a number of different ways according to embodiments. For example, in some embodiments, the valve seat 4 may be formed by the material forming the valve body 11 in which the ferromagnetic ring 5 is disposed.

[0053] The portion of the valve seat 4 configured to contact the valve element 14 may have a radius that matches or substantially matches the outer radius of the valve element 14. In some embodiments, the portion of the valve seat 4 configured to abut the valve element 14 may be configured to elastically deform upon contact with the valve element 14. Such a configuration may be configured to improve the seal between the valve seat 4 and the valve element 14.

[0054] In some embodiments, the seat 4 may include a coating of, impregnated with, or otherwise include additives in the form of a seat material. The seat material may include antibacterial and / or antifungal agents, and / or ferromagnetic materials (which may be in powder form), and / or hydrophilic or hydrophobic materials. The use of the seat material may thus aim to improve the seal between the seat 4 and the valve element 14 and / or reduce the accumulation of microbial matter on the seat 4.

[0055] In some embodiments, a separate ferromagnetic ring 5 may not be used. For example, the valve seat 4 (and / or the valve seat member 41) may be formed from an elastomer (e.g., silicone) that includes a filler material, such as tiny steel or iron spheres or powder. In some embodiments, the ferromagnetic ring 5 is provided as a separate piece from the valve seat 4 (and / or the valve seat member 41), but is itself formed from an elastomer (e.g., silicone) that includes a filler material, such as tiny steel or iron spheres or powder.

[0056] Thus, in some embodiments, the end face of the first end of the ferromagnetic ring 5 may be covered with the material forming the valve body 11. Two examples of this are shown in Figures 3a and 3b.

[0057] In some embodiments, for example, referring to FIG. 3a, the material of the valve body 11 covers an end face of the first end of the ferromagnetic ring 5. However, in this and some other embodiments, at least a portion of the passage through the valve 1 may be defined by the ferromagnetic ring 5, for example, allowing fluid passing therethrough to contact the ferromagnetic ring 5 (or at least a portion thereof). The valve seat 4 in these embodiments may be formed by the material covering the end face of the first end of the ferromagnetic ring 5.

[0058] In some embodiments, for example, referring to Figure 3b, the material of the valve body 11 covers the end face of the first end of the ferromagnetic ring 5 (similar to the embodiment of Figure 3a), but the remainder of the ferromagnetic ring is also substantially covered by the material of the valve body 11, such that fluid passing therethrough does not contact (or at least does not contact a substantial portion of) the ferromagnetic ring 5. The valve seat 4 in these embodiments may be formed by the material covering the end face of the first end of the ferromagnetic ring 5.

[0059] In some embodiments, a separate valve seat member 41 is provided to form the valve seat 4. This separate valve seat member 41 may be disposed adjacent to an end face of the first end of the ferromagnetic ring 5 and may be secured to the ferromagnetic ring 5 and / or may be at least partially embedded in the material of the valve body 11. The valve seat member 41 may be formed, for example, of an elastomeric material that is stiffer than the valve body 11 or may otherwise have one or more properties that enhance the seal between the valve element 14 and the valve seat 4 (compared to using the material of the valve body 11 for the valve seat 4). In some embodiments, the valve seat member 41 may improve consistency in the formation of the valve seat 4 (again, compared to using the material of the valve body 11 for the valve seat 4). The valve seat member 14 may be formed from a different durometer silicone than the valve body 11 (which may also be formed from silicone).

[0060] Valve 1 is actuable between an open configuration and a closed configuration. In the open configuration, valve element 14 is spaced from valve seat 4, thereby allowing fluid to flow around valve element 14 and through outlet 25. In the closed configuration, valve element 14 is secured to valve seat 4, thereby substantially sealing outlet port 25 from fluid communication with inlet port 112.

[0061] As will be appreciated, the valve element 14 may be biased towards the closed configuration due to magnetic attraction to the ferromagnetic ring 5. Additionally, when the valve 1 is placed in the urethra as an intraurethral valve and oriented relative to the normal flow of fluid therethrough, the inlet port 112 may be upstream of the outlet port 25 having fluid, such that the flow of fluid through the valve 1 may also help bias the valve element 14 towards the closed configuration.

[0062] Solely by way of example, one embodiment (the embodiment of Fig. 3b) is shown in Fig. 4a in a closed configuration and in Fig. 4c in an open configuration, Fig. 4b showing a variant in an open configuration in which a passage through the valve 1 is provided to allow passage of the expandable element 50 for insertion of the valve 1 into a patient - for example using the implantation system of WO 2008 / 067557 or variants thereof.

[0063] Actuation of valve 1 to the open configuration may be achieved through the use of magnetic member 15 (see FIG. 13). Magnetic member 15 may be positioned external to the patient to which valve 1 is attached and moved into relative proximity to valve 1 to achieve actuation from the closed configuration to the open configuration (by exposing valve 1 to the magnetic field of magnetic member 15).

[0064] Actuation to the closed configuration may be achieved by magnetic attraction between the valve element 14 and the ferromagnetic ring 5 and may be assisted by one or both of gravity and fluid flow through the valve 1, for example.

[0065] The valve 1 described herein may be installed in a male or female patient as an intraurethral magnetic valve 1. With reference to Figure 1, the valve 1 described herein may be substituted for the valve (1) shown in Figure 1 and described in the document from which it is excerpted - see above for details of the document.

[0066] As will be appreciated, the valve 1 is substantially formed of a relatively flexible material, such as an elastomeric material. In some embodiments, only the valve element 14 and the ferromagnetic ring 5 are not formed of such a material (and in some embodiments the valve seat member 41 may be formed of a different material).

[0067] Providing such a valve 1 may alleviate discomfort in some circumstances because of the reduced bulk of the design compared to some other valves and / or because a majority of the valve 1 is formed from a relatively flexible material (e.g., relatively flexible compared to valve element 14 and ferromagnetic ring 5). The reduced bulk and / or flexible body of valve 5 may also aid in insertion into the urethra.

[0068] The valve body 11 can be formed of a relatively flexible material (such as an elastomeric material), as described above. Thus, the exterior surface of the valve body 11 may be formed of such a material. This can, for example, aid in forming a seal between the valve 1 and the urethral wall. This can help reduce leakage of fluid around the valve 1.

[0069] The external width (which may be a diameter) of the valve 1 may be substantially the same as or slightly larger than the width of the portion of the urethra where the valve 1 is intended to be placed - see below for the location of the valve 1. A number of different widths of the valve 1 may be provided, for example for various urethral portion widths, so that a relatively snug fit can be achieved. At least a portion of the exterior surface of the valve 1, e.g. a portion of the valve body 11, may be configured to elastically deform upon insertion into the urethra. At least a portion of the exterior surface of the valve 1, e.g. a portion of the valve body 11, may be configured to elastically deform with the valve 1 in its intended position. This at least a portion may be intended to remain elastically deformed with the valve 1 in its intended position, although the exact shape of the deformation may change over time.

[0070] In some embodiments, the valve 1 includes one or more external features configured to increase engagement between the valve 1 and the urethral wall. These one or more external features may be formed on an exterior portion of the valve body 11 and may be features configured to elastically deform (e.g., as described above).

[0071] The one or more external features may include one or more ribs or other protrusions and may extend generally radially outward from the valve body 11. In some embodiments, the or each external feature may include at least one circumferential rib that may extend around all or substantially a portion of the circumference of the valve body 11.

[0072] In some embodiments, at least one of the one or more external features has a corresponding internal feature within the interior valve volume 111. For example, the bulbous portion 111a may have a corresponding external rib 111b that is at least partially defined by the valve body 11.

[0073] Further embodiments of the valve 1 are shown in Figures 24a-24d, 25a-25b, 27a-27d, and 28a-28b.

[0074] With reference to Figures 24a-24d, the valve 1 may include an inlet end and an outlet end (with the outlet port 25 generally located at the outlet end and the inlet port 112 generally located at the inlet end).

[0075] The valve body 11 may include a tubular body, and the valve seat 4 may be disposed therein and may be integrally formed with the valve seat. The outlet port 25 may be offset relative to the central longitudinal axis of the valve 1 - such an offset valve seat 4 is described elsewhere herein.

[0076] Thus, the tubular body of the valve body 11 may form a cup-shaped member having an opening (exit port 25) therethrough and an opposing open end.

[0077] The open end of the tubular body 11 (e.g., the tubular body toward the inlet end) may be configured to receive the tubular plug 112a. The tubular plug 112a may be configured to be at least partially received by the tubular body 11 to define the interior valve volume 111. In manufacture, the spherical magnetic valve element 14 may be placed with and secured to the tubular body 11 and the tubular plug 112a. An adhesive may be used to help secure the tubular body 11 and the tubular plug 112a. The tubular plug 112a may define the inlet port 112 and may be integrally formed with (or attached to) the catheter 16, for example. The end of the tubular plug 112a may include a plurality of teeth. The teeth may extend longitudinally or may be spaced circumferentially. The provision of such teeth may result in increased radial flexibility of the end of the tubular plug 112a. The teeth may be received by the tubular body 11.

[0078] The outer wall of the tubular plug 112 a may have a diameter that tapers away from the portion that is received (or can be received) by the tubular body 11 .

[0079] The outlet port 25 may be in fluid communication with an outlet tube 251 of the valve 1. The outlet tube 251 may have a smaller outer diameter than the tubular body 11 of the valve 1.

[0080] The ferromagnetic ring 5 may be configured to fit over at least a portion of the outlet tube 251. The ferromagnetic ring 5 may be configured to be disposed around at least a portion of the outlet tube 251 and / or the tubular body 11 such that it is disposed in relation to the valve seat 4.

[0081] An annular cover member 51 may be disposed over the ferromagnetic ring 5. This annular cover member 51 may be configured to pass over a portion of the outlet tube 251 and may be secured thereto and / or to the ferromagnetic ring 5 and / or to the tubular body 11. An adhesive may be used to secure the ferromagnetic ring 5 and / or the annular cover member 51 in place.

[0082] The outer diameter of the annular cover member 51 may taper away from the tubular body 11 .

[0083] The arrangement of the spherical magnetic valve element 14 including the ferromagnetic ring 5 and the annular cover member 51 with respect to the offset valve seat 4 (closed configuration) is shown, for example, in FIG.

[0084] Another embodiment is shown in Figures 27a-27d and 28a-28b. In this embodiment, the inlet end tubular plug 112a is generally of the same form as the previous embodiment. However, in this and such embodiments, an outlet port tubular plug 25a is also present.

[0085] Thus, the tubular body 11 may be configured to receive at least a portion of the inlet and outlet tubular plugs 112a, 25a at either end thereof.

[0086] The inlet tubular plug may be at least partially received by the internal valve volume 111. In some embodiments, the tubular body 11 may define an outlet volume 1111 configured to receive at least a portion of the outlet tubular plug 25a. The outlet volume 1111 may further be configured to receive a ferromagnetic ring 5, which may be glued in place and / or held in place by the outlet tubular plug 25a. The end of the outlet tubular plug 25a received by the outlet volume 1111 may include teeth in the same manner as the inlet tubular plug 112a described herein. The outer diameter of the outlet tubular plug 25a may taper away from the tubular body 11.

[0087] The valve seat 4 may be integrally formed with the tubular body 11 or may be fixed to the inside of the tubular body 11 .

[0088] In some embodiments, the valve seat 4 may be part of a valve seat member 41 that may be fixed to the tubular body 11. Several embodiments of the valve seat 4 are described with reference to Figures 31a-31f. The valve seat 4 may be generally of the same shape as the tubular body 11, for example when integrally formed therewith.

[0089] The valve seat 4 may be an offset valve seat - for example, having the outlet port 25 offset from its central longitudinal axis (the central longitudinal axis being parallel to the normal direction of fluid flow through the seat member 41).

[0090] The valve seat 4 (which may be part of the valve seat member 41) may define a cup-like structure through the base in which the outlet port 25 may be provided. Thus, the valve seat 4 may be configured to receive at least a portion of the spherical magnetic valve element 14.

[0091] The valve seat 4 may be shaped such that a portion of the valve element 14 is received by the valve seat 4 when the valve 1 is in the closed configuration. In some embodiments, at least 10% of the valve element 14 is so received. In some embodiments, at least 20% of the valve element 14 is so received. In some of these and other embodiments, less than 50% of the valve element 14 is received by the valve seat 4 in this manner.

[0092] The cup-shaped valve seat 4 of some embodiments may similarly be described as bowl-shaped.

[0093] As mentioned above, the valve seat 4 may be formed of a resiliently deformable material (e.g., an elastomer) such that when in the closed configuration, the valve element 14 deforms at least a portion of the valve seat 4. This may allow for greater tolerances regarding the location and shape of the valve seat 4 and / or the valve element 14.

[0094] Similarly, the elastically deformable valve seat 4 and / or the cup-shaped seat configuration can improve sealing (in the closed configuration) despite any material build-up (i.e., fouling) on ​​the valve 1. The valve element 14 may also be coated with an antibacterial and / or antifungal material, with either or both of these features making it more practical (e.g., because it has a wider tolerance range).

[0095] Due to the offset configuration of the valve seat 4 in some embodiments, the valve seat 4 may include a circumferentially inclined surface configured to contact the spherical magnetic valve element 14, and the radial depth of the valve seat 14 may be greater in one portion compared to the opposing portion. An example of the inclination angle of the valve seat 14 is shown in FIG. 31c, by way of example only. In some embodiments, the angle shown may be ±10-20%.

[0096] The seat member 41 may have a first outer diameter in the region of the valve seat 4, which is larger than a second outer diameter of the seat member 41 in the region of the outlet port 25. This may, for example, allow for attachment of the seat member 41 to the tubular body 11 and / or the outlet tubular member (which may be in fluid communication with the outlet port 25). The reduced diameter (i.e. the second outer diameter) may be configured to allow the ferromagnetic ring 5 to pass through and be fixed to the seat member 41.

[0097] 32a and 32b, the tubular body 11 may define one or more internal elongated ribs 11a, each of which may extend into the interior valve volume 111. The, or each, internal elongated rib 11a may be arranged generally parallel to the longitudinal axis of the tubular body 11. In some embodiments, there are a plurality of such elongated ribs 11a spaced apart about the inner circumference of the tubular body 11. The, or each, internal elongated rib 11a may extend from the inlet end towards the outlet end of the tubular body 11. The, or each, internal elongated rib 11a may help guide the valve element 14 and / or reduce the risk of the valve element 14 adhering to the body 11.

[0098] 29a-30d show in various views an embodiment which includes the previously described valve seat member 41 as part of the valve 1 in a similar manner as described elsewhere herein.

[0099] 29d as an example of a valve 1, the seat member 41 may be configured to close or substantially close the outlet end of the tubular body 11 (taking into account, of course, that the seat member 41 defines the outlet port 25). The seat member 41 may thus form an outlet end plug. A ferromagnetic ring 5 may be provided around at least a portion of the seat member 41 and may be received within the tubular body 11. An adhesive may be used to secure the seat member 41 and / or the ferromagnetic ring 5 to the tubular body 11.

[0100] The seat member 41 and the ferromagnetic ring 5 may be sized and shaped accordingly to allow the ferromagnetic ring 5 to fit around at least a portion of the seat member 41. In some embodiments, the seat member 41 and the ferromagnetic ring 5 are fixed such that the rotational position between the two parts may be controlled (e.g., allowing for single or discrete multiple relative rotational positions with respect to each other when attached).

[0101] In some embodiments, the valve 1 may include an external sealing member 113. Examples of external sealing members 113 are shown generally in Figures 7a-7d.

[0102] In particular, the external seal member 113 may be disposed on the exterior of the valve body 11 and may extend around a portion of its exterior surface. In some embodiments, such as the one illustrated, the seal member 113 is a generally annular member that extends around substantially the entire circumference of the valve body 11. The external seal member 113 may be formed of a different material than the valve body 11, e.g., a softer material. In some embodiments, the external seal member 113 may be a foam material, such as a foamed elastomeric material. The external seal member 113 (which may be a foam material) may be impregnated with or coated with an antimicrobial material and / or formed from an antimicrobial material. Additionally or alternatively, the external seal member 113 (which may be a foam material) may be impregnated with or coated with a hydrophilic material and / or formed from a hydrophilic material. Thus, at least a portion of the length of the catheter 16 may have a hydrophilic coating (whether or not provided by the external seal member 113).

[0103] The external seal member 113 may be configured to provide an improved seal between the valve and the urethra to reduce the possibility of leakage around the valve 1. In some embodiments, the seal member 113 can help maintain the valve 1 positioned within the urethra.

[0104] In the example of FIG. 7 a , an external seal member 113 is disposed at the end of the valve 1 towards the inlet port 112 , and may in fact be disposed around a portion of the catheter 16 coupled to the valve 1 .

[0105] In the example of Figure 7b, an external seal member 113 is positioned around a portion of the valve body 11 towards the end of the valve 1 with the inlet port 112 (e.g., between the external rib 111b and the inlet port 112, if provided).

[0106] In the example of FIG. 7c, the external seal member 113 is positioned around a portion of the valve body 11 towards the end of the valve 1 with the outlet port 25 (e.g., between the external rib 111b and the outlet port 25, if provided).

[0107] In the example of FIG. 7 d , the external sealing member 113 is in the form of a coating that covers substantially all of the valve body 11 from the end with the inlet port 112 to the end with the outlet port 25 .

[0108] In some embodiments, there may be a variety of seal members 113, which may be any combination of seal members 113 described herein and shown in Figures 7a-7d. Thus, for example, there may be a two-seal outer seal member 113, including member 113 of Figure 1 and member 113 of Figure 2, or member 113 of Figure 2 and member 113 of Figure 3. In some embodiments, there may be a three-seal outer seal member 113, including member 113 of Figure 1 and member 113 of Figure 2 and member 113 of Figure 3. The seal member 113 of Figure 7b may include one or more rib portions to provide a corresponding seal member portion for the seal members 113 shown in one or more of Figures 7a-7c.

[0109] As mentioned above, the valve 1 may be coupled to a catheter 16. The catheter 16 provides and defines a fluid flow path to the valve 1, and in particular to the inlet port 112 of the valve 1. The valve 1 may be an intraurethral valve 1, and thus the catheter 16 may be coupled to a retention mechanism configured to secure or help secure the valve 1 and catheter 16 in a desired position.

[0110] The retention mechanism can take a variety of forms and is configured to pass through the urethra to a desired location before being deployed. Once deployed, the retention mechanism serves to hold the catheter 16 and / or valve 1 in place. In some cases, deployment generally refers to the expansion or extension of at least a portion of the retention mechanism.

[0111] In some embodiments, the retention mechanism may include a malecot as shown in Figure 1. The retention mechanism may include multiple arms or loops or rings 28 that, when deployed, act to limit movement of the catheter 16 and / or valve 1 coupled to the retention mechanism. Thus, the arms or loops or rings 28 are transitionable from a non-deployed or retracted configuration to a deployed or extended configuration. As used herein, the arms or loops or rings 28 are examples of deployable members 28 of the retention mechanism, as that term is used hereinafter.

[0112] Thus, in some embodiments, a valve system 100 is provided that includes a valve 1, a catheter 16, and a retention mechanism.

[0113] The length of catheter 16 from valve 1 to the retention mechanism may be selected based on the desired placement of valve 1, for example, as described herein.

[0114] The retention mechanism may include a plurality of deployable members 28, as described above. These deployable members 28 may extend radially outward relative to the catheter 16 such that when deployed, they define a portion of the system 100 that is wider than the catheter 16 (but may be retracted to be substantially the same width as the catheter 16 when in a non-deployed configuration, for example). The deployable members 28 may define spaces between them. These spaces may provide fluid communication between a volume surrounding the retention mechanism and the lumen 21 defined by the catheter 16. In the case of an intraurethral system, this volume may be the bladder 29.

[0115] Thus, similar to FIG. 1, the retention mechanism may be located at the bladder neck 22 with the catheter 16 extending down the urethra (in terms of the direction of normal fluid flow).

[0116] As described above in this specification, the valve 1 of some embodiments may be inserted or implanted using, for example, the systems disclosed in WO 00 / 02499 and / or WO 2011 / 032150, the details of which are incorporated by reference in their entireties.

[0117] Generally, referring briefly to the teachings of documents such as WO 00 / 02499 and / or WO 2011 / 032150, the insertion of the valve system 100 may include removably connecting the valve system 100 to an insertion tool 200. The expandable element 50 described above extends from the tool 200 through the outlet port 25 of the valve 1, through the internal valve volume 111, through the catheter 16 to the retention mechanism, with the valve 1 in the configuration shown in FIG. 4b, hereinafter referred to as the open-patient configuration. An end (i.e., the proximal end) of the expandable element 50 is removably secured to the retention mechanism.

[0118] The expandable element 50 may be a wire or the like and is configured to be pushed towards the retention mechanism, for example using the insertion tool 200, to stiffen the valve system 100 for insertion. This action also places the retention mechanism in an undeployed (or retracted) configuration to facilitate easier passage through the urethra.

[0119] Once the retention mechanism is in the desired location (e.g., within the bladder), the expandable element 50 can then be detached and withdrawn from the valve system 100 while the retention mechanism is deployed, and the insertion tool and expandable element 50 can be removed.

[0120] As can be seen from both WO 00 / 02499 (Patent Document 2) and WO 2011 / 032150 (Patent Document 4), removal and withdrawal of the expandable element 50 may require the use of a locking wire or a magnetic element to allow the expandable element 50 to remain captured by the retention mechanism until it is desired to remove and extract the expandable element 50.

[0121] One embodiment provides a retaining clip 501 for the expandable element 50 - see, for example, FIG.

[0122] The retaining clip 501 may be an elongated clip configured to be selectively attached around the expandable element 50, allowing a portion of the retaining clip 501 to extend beyond the area of ​​the retention feature, and in this case, beyond the deployable member 28. The retaining clip 501 may be configured to resist, and thus substantially prevent, movement along the length of the expandable element 50 when secured to the expandable element 50 (which may be in the form of a wire or thin tube). Thus, the retaining clip 501 may inhibit the expandable element 50 from moving further into the catheter 16 by the clip abutting at least a portion of the retention feature (e.g., the deployable member 28 or one or more of the components to which the deployable member 28 is attached) or an end of the catheter 16 itself.

[0123] The retaining clip 501 allows the valve system 100 to be stored for use with the expandable element 50 attached to the retention mechanism (otherwise the proximal end of the valve system 100). The valve system 100 may also be stored for use with the insertion tool 200. The retaining clip 501 can reduce the risk of the expandable element 50 being accidentally or mistakenly detached from its connection with the proximal end of the valve system 100 (e.g., the retention mechanism). Prior to use (i.e., insertion) of the valve system 100, the retaining clip 501 would be removed.

[0124] The retaining clip 501 can take a number of different forms.

[0125] 8 and 9a, by way of example only, the retaining clip 501 may include first and second hinged elongate members 501a, 501b. The first and second elongate members 501a, 501b may be coupled to one another at one end by a hinge 501c, which allows the two elongate members 501a, 501b to move relative to one another about the hinge (see FIG. 9b).

[0126] The first and second elongate members 501a, 501b may be formed from a plastic material, and the hinge 501c may also be formed from a plastic material (although it may be thinner than the material of the first and second elongate members 501a, 501b).

[0127] Away from the hinge 501c, the first and second elongated members 501a, 501b may be configured to engage, and for this purpose the retaining clip 501 may include an engagement mechanism 501d. The engagement mechanism 501d may include a portion of one of the first and second elongated members 501a, 501b that is configured to clip around a portion of the other of the first and second members 501a, 501b. One or both of these portions may be configured to elastically deform when the retaining clip 501 moves from the open configuration to the closed configuration, such that the engagement mechanism holds the two elongated members 501a, 501b together and substantially prevents movement of one of the elongated members 501a, 501b around the hinge 501c relative to the other of 501a, 501b (see FIG. 9c).

[0128] The engagement mechanism may be selectively and manually releasable, allowing the retaining clip 501 to assume an open configuration by movement of one or both of the engaging portions out of engagement and by rotation of one of the elongate members 501a, 501b relative to the other of 501, 501b about hinge 501c. Once the retaining clip 501 is in the open configuration, it can be removed from the expandable member 50.

[0129] The retaining clip 501 can take a number of different forms. For example, the retaining clip 501 can be in the form of a U-shaped member that defines a slit between two prongs. The expandable member 50 can be received by the slit if it is narrower than the diameter of the expandable member 50 to sandwich the expandable member 50 between the two prongs of the retaining clip 501.

[0130] In some embodiments of the retaining clip 501, the slit narrows with the depth between the prongs, allowing the clip 501 to press against the expandable member 50, sandwiching the member 50 between the prongs.

[0131] Thus, in some embodiments, the elongate members 501a, 501b may not be joined by a hinge, but rather form the protrusions mentioned above.

[0132] In some embodiments, the engagement mechanism may be such that it must be cut to allow the retaining clip 501 to be removed from the expandable member 50. For example, the engagement mechanism may include a weld, e.g., a plastic weld, of the two elongate members 501a, 501b to one another. This may, for example, prevent reuse of the retaining clip 501.

[0133] In some embodiments, a valve system 100 is provided in combination with an expandable member 50 and a retaining clip 501. In some embodiments, this combination may include an insertion tool 200 and thus may be referred to as a valve kit (a kit that includes the means by which the valve system 100 may be inserted or otherwise implanted). In some embodiments, the valve kit may include an insertion tool 300 of various forms (e.g., of the forms described herein below).

[0134] Valve system 100 may include one or more tethers 101 for use in removing valve system 100 from a patient. The or each tether 101 may comprise a thread or wire, which may extend downward (relative to the normal direction of fluid flow) through the urethra and out of the patient.

[0135] For extraction, the or each tether 101 may be grasped (e.g., using a suitable clamping tool) and used to pull the valve system 100 downwards (against the normal direction of fluid flow) through the urethra, thereby collapsing the retention mechanism and allowing it to pass through the urethra. The or each tether 101 may be sufficiently strong to allow this to happen. The or each tether 101 may be of sufficient length to allow it to be accessed externally or nearly externally through the urethra.

[0136] In some embodiments, the or each tether 101 is fixed to the valve 1. The or each tether 101 may, for example, be fixed to or around at least a portion of the ferromagnetic ring 5 and / or the valve seat member 41. This may help to prevent the or each tether 101 from cutting through the material of the valve body 11, for example, during extraction of the valve system 100. In some embodiments, the or each tether 101 may include at least a portion that is spirally wound and embedded within the valve body 11 (which allows portions of the or each tether 101 to extend around the valve body 11 multiple times) - again, this may help to prevent the tether 101 from cutting through the material of the valve body 11, during extraction of the valve system 100.

[0137] Prior art valve systems typically place the valve in the bulbar urethra 26. Valve system 100 of the embodiments may be similarly formed such that valve 1 is placed in the bulbar urethra 26. However, in some embodiments, valve 1 may be placed in the pendular urethra 27, and valve system 100 may be configured accordingly (e.g., with respect to the length of catheter 16).

[0138] Locating the valve in the pendular urethra 27 may have one or more advantages, such as facilitating actuation of the valve with magnetic member 15 and / or reducing tenderness caused by the patient sitting when the valve 1 is higher in the urethra.

[0139] Ease of placement of the valve 1 into the pendular urethra 27 may be aided by the lower bulk and / or increased comfort required by some embodiments.

[0140] In some embodiments, there may be additional external sealing members 113 disposed along the catheter 16 with the valve 1 disposed at the pendular urethra 27. These additional external sealing members 113 may be disposed, for example, at one or more of the bladder neck 22, the prostatic urethra 23, the external sphincter 24, and the bulbar urethra 26. In some embodiments, the or each additional external sealing member 113 may generally be of the same form and configured similarly as described above with respect to the external sealing member 113 (e.g., made of the same materials and / or annular as described above). In some embodiments, the or each external sealing member 113 disposed along the length of the catheter 16 and / or valve 1 may have one or more different sealing characteristics.

[0141] Some embodiments may be configured for implantation in the female urethra, and an example of a valve system 100 for a female patient can be found in Figure 11. Such a valve system 100 for a female patient may include a retention mechanism for placement in the bladder 29, a catheter 16 extending through the urethra, and a valve 1. Because the length of the female urethra is shorter, the catheter 16 may be shorter than in the valve system 100 for a male patient.

[0142] In some embodiments, the female urethral valve system 100 may have the valve 1 disposed along the length of the catheter 16, rather than at the distal end of the catheter 16 (as in the above embodiment). In practice, this may be achieved by having a first catheter 161 extending from the retention mechanism to the valve 1 (and in particular the inlet port 112 of the valve 1), and a second catheter 161 extending from the valve 1 (and in particular the outlet port 25 of the valve 1) to the distal end of the valve system 100.

[0143] In some embodiments, the valve system 100 may include a second retention mechanism, which may be referred to as an external retention mechanism 282. The (first) retention mechanism at the proximal end of the valve system 100 may be configured to reduce the risk of the valve system 100 migrating out of position and down the urethra (relative to normal fluid flow therethrough), while the external retention mechanism 282 may be configured to reduce the risk of the valve system 100 migrating into the bladder 29.

[0144] Thus, in some embodiments of the valve system 100 (which may be embodiments intended for female patients), the valve system 100 may have separate retention mechanisms on each of the opposing ends of the valve system 100.

[0145] In some embodiments, the first retention mechanism (for attachment to the interior of the bladder 29, which may be referred to as an internal retention mechanism) may be in a form similar to that described in the above embodiments and may thus include a plurality of deployable members 28 configured to move between a non-deployed (or retracted) configuration and a deployed (or expanded) configuration. The deployable members 28 may be in the form of, for example, arms or loops or rings 28. In the illustrated example of FIG. 11, the deployable members 28 are in the form of arms. The first retention mechanism may be in the form of a malecot.

[0146] The external retention mechanism 282 may have a different form than the first retention mechanism. In some embodiments, the external retention mechanism 282 may include an adjustable retention ring, which may be configured to be positioned at the urethral outlet between the labia folds. Thus, the retention ring may be adjustable to fit between the labia folds, but large enough to reduce the likelihood of the retention ring entering the urethra. The adjustable retention ring may be in the form of a drawstring around the neck of the catheter 16 at the distal end of the catheter 16.

[0147] In some embodiments, the distal end of the catheter 16 may extend through, and be concentric with, an adjustable retaining ring.

[0148] In some embodiments, the catheter 16 and / or the external retention mechanism 282 may be configured to be cut to adjust the length of the valve system 100.

[0149] The external retention mechanism 282 may include a foam pad (which may be formed of a foam material as described herein and may carry an antimicrobial agent). In some embodiments, the foam pad may be configured to be cut to a desired size and / or shape (and may include one or more guide lines (e.g., printed thereon for this purpose)).

[0150] Yet another embodiment is shown in Figures 21a to 21d, which is a variation of the embodiment described, for example, with reference to Figures 11 and 12a to 12c.

[0151] In this embodiment, various dimensions are provided in the figures by way of example only. Dimensions are given in mm.

[0152] In some embodiments, including the illustrated embodiment of Figures 21a-21d, there may be multiple retention members 28 (eg, two, three, four (as shown), five, or more).

[0153] The second retaining feature 282 may include, for example, a foam member (or pad). The foam member may be held in place via an annular retainer 2821 disposed around at least a portion of the catheter 16. The retainer 2821 may be glued to the catheter 16, for example. An outer surface of the annular retainer 2821 may be adjusted to fit into a corresponding recess in the second retaining feature 282. The second retaining feature 282 may be glued to the annular retainer 2821, for example. The second retaining feature 282 may be offset relative to the catheter 16. The second retaining feature 282 may be generally elliptical, for example.

[0154] The valve seat 4 in the embodiment described with reference to Figures 21a-21d may be a valve seat 4 described elsewhere herein or may be part of a valve seat member 41.

[0155] The ferromagnetic ring 5 in the embodiment described with reference to Figures 21a-21d may be a ferromagnetic ring 5 described elsewhere herein. For example, the ferromagnetic ring 5 may be in the form of, for example, an annular collar. The ferromagnetic ring 5 may, for example, extend around at least a portion of the valve seat member 41. The ferromagnetic ring 5 may be surrounded by at least a portion of the valve body 11 or may be mounted within the valve body 11.

[0156] Valve body 11 may be at least partially tubular such that valve seat 4 fits within valve body 11. Catheter 16 may also be at least partially received by valve body 11 and may be adhered thereto such that outlet port 16 is in fluid communication with catheter 16.

[0157] The ferromagnetic ring 5 may be glued to the valve seat 4 and / or may be held in place by the catheter 16 (which may be glued to the valve body 11).

[0158] Figures 22a and 22b show different views of the embodiment described with reference to Figures 21a to 21d.

[0159] Figure 23a shows the embodiment of Figures 21a-21b with the valve 1 in an open configuration, and Figure 23b shows the same embodiment with the valve 1 in a closed configuration.

[0160] In some embodiments, there may be one or more external seal members 113 at or towards the distal end of the valve system 100 of these embodiments. The or each external seal member 113 may include a seal member disposed on the external retention mechanism 282. The or each external seal member 113 may generally be of the same form as described above and may be configured to reduce the risk of leakage between the valve system 100 and the urethral wall. The or each external seal member 113 may include a generally annular external seal member 113 disposed between the external retention mechanism 282 and a location adjacent the urethra. This may provide some sealing effect, but may also reduce irritation at this location. One or more additional external seal members 113 may be disposed along the length of the catheter 16 (which in some embodiments may be the first or second catheter 161, 162). Each of these additional external seal members 113 may be configured to help reduce the likelihood of leakage between the valve system 100 and the urethral wall.

[0161] Reference is made to the placement of valve 1 along the length of catheter 16, and the provision of first and second catheters 161, 162 on either side of valve 1. However, Figure 11 does not show valve 1. Examples of placement of valve 1 are therefore shown in Figures 12a-c.

[0162] In FIG. 12a, valve 1 is positioned adjacent the distal end of the valve system 100 and proximate to the external retention mechanism 282 (where "proximate" can mean, for example, closer to the external retention mechanism 282 than to the first retention mechanism).

[0163] In FIG. 12b, valve 1 is positioned approximately halfway between the outer retention feature 282 and the first retention feature.

[0164] In FIG. 12c, valve 1 is positioned adjacent the proximal end of the valve system 100 and in close proximity to the first retention feature (where "close" can mean, for example, closer to the first retention feature than the external retention feature 282).

[0165] 11 and 12a-12c all show the valve system 100 with an insertion tool 200 that can be used with some embodiments. This insertion tool 200 may be configured for use with shorter valve systems 100, such as those for female patients. Thus, the insertion tool 200 may differ from the insertion tool 200 described above with respect to some other embodiments.

[0166] The insertion tool 200 may include a relatively stiff sleeve member 201 in some embodiments. The sleeve member 201 may be stiffer than the valve system 100 to allow the insertion tool 201 to be pushed into and through the urethra. The sleeve member 201 may be of a tubular form defining a lumen, and the lumen may be configured to receive the valve system 100 (or a portion thereof). The insertion tool 200 may have a neck portion 202, which generally has a lumen width or diameter greater than the lumen width or diameter of the main portion 203 of the insertion tool 200. The inner and / or outer diameter of the insertion tool 200 may be tapered toward one or both ends thereof.

[0167] The insertion tool 200 may be inserted into the urethra without the valve system 100 received therein. The valve system 100 may then be threaded through the insertion tool 200 until the first retention mechanism deploys within the bladder 29. The insertion tool 200 may then be removed and any necessary adjustments made to the external retention mechanism 282. Alternatively, the insertion tool 200 may have the valve system 100 at least partially provided therein. The combination of the insertion tool 200 and the valve system 100 may then be inserted into the urethra and the same process may follow. This latter option allows for the use of a more flexible insertion tool 200, which may, for example, reduce the risk of damaging the urethral wall. An embodiment may include, for example, the insertion tool 200 in combination with the valve system 100.

[0168] Some embodiments have been described as including an external seal member 113. One or more such external seal members 113 may be provided not only with respect to the valve 1, but also (or alternatively) with respect to the catheter 16. This may include, for example, a coating covering a substantial portion of the exterior surface of the catheter 16 and / or the valve 1. In some embodiments, there are multiple external seal members 113 that form circumferential ribs around portions of the valve system 100. In some embodiments, the coating material that forms the external seal members 113 may include one or more circumferential ribs of material along the length of the valve system 100.

[0169] In some embodiments, the or each external seal member 113 may be configured to expand when exposed to a liquid (such as water) to improve the seal between the valve system 100 (or a portion thereof) and the urethral wall. The or each external seal member 113 may be formed of a material as described above. In some embodiments, the or each seal member may be formed from a hydrogel material or other polymeric gel material. This material may be a silicone material. In some embodiments, the or each external seal member 113 may be formed from CRM (cotton rayon mixes), such as those used in TAMPAX® tampons or compressed Gelfoam®.

[0170] The material used for the or each outer seal member 113 may include, for example, antibacterial and / or antifungal agents which may be impregnated into the material.

[0171] The material used for the or each outer seal member 113 may include, for example, an anaesthetic which may be impregnated into the material. Such an anaesthetic may help to reduce discomfort, particularly immediately after implantation.

[0172] Additionally, as discussed herein, one of the outer seal members 113 may differ in configuration and / or material from another of the outer seal members 113.

[0173] In some embodiments, the or each outer seal member 113 may include a material that changes color upon exposure to one or more microbial types and / or their secretions. This may allow, for example, assessment of the impact of such microbial organisms upon removal of the valve system 100. In some embodiments, this may determine, for example, what antibacterial and / or antifungal agents should be used for a new valve system 100 for the same patient.

[0174] In some embodiments, the or each external seal member 113 may include an inflatable member 1131 (see FIG. 14). The inflatable member 1131 may be inflatable with saline or silicone or polymer gel or another fluid. Inflation fluid for the or each inflatable external seal member 1131 may be provided via a tube that may extend along an outer surface of at least a portion of the valve system 100 or may extend through at least a portion of the valve system 100 (e.g., through the valve 100 and / or catheter 16). The or each inflatable external seal member 1131 may include a valve system for retaining the inflation fluid and may allow for removal of the tube that provided the inflation fluid. In some embodiments, the or each inflatable external seal member 1131 is a seal member that may be compressed for insertion into the urethra, for example, by a restrictive band, and following insertion into the desired location, the compression may be removed, for example, by removal of the restrictive band. Removal of the compression may allow the inflatable external seal member 1131 to expand.

[0175] In some embodiments, one or more external seal members 113 may be provided, which may be secured to the valve system 100 when the valve system 100 is implanted. In some embodiments, the, or each such external seal member 113 may include an annular member 1132 (see, e.g., FIGS. 15 and 16 ), which may be slid along the length of at least a portion of the valve system 100. There may be multiple such external annular seal members 1132, which may have different outer diameters, allowing for the use of an external seal member 113 that provides the best seal for a particular patient—see FIG. 16 , which shows two such members 1132. In some embodiments, the inner diameter (or another dimension—see the dimension of the hole 1132a defined by each member 1132) of each such external seal member 1132 may be configured to provide a close fit with a portion of the valve system 100. In some embodiments, the or each such external seal member 1132 may be configured to expand when exposed to liquid (see discussion above), which may allow the external seal member 1132 to be more easily slid into place before the expansion causes the member 1132 to form a seal against the valve system 100. In some embodiments, the inner diameters (or another dimension) of a set of external seal members 1132 may be such that a first external seal member 1132 is configured to form a seal against a portion of the valve system 100, a second external seal member 1132 is configured to form a seal against the first external seal member 1132, and so on. Thus, the inner diameters (or another dimension) of the set of external seal members 1132 may be progressively larger, and the outer diameters may be progressively larger as well (in some embodiments, the inner diameter of the second external seal member 1132 matches (e.g., is substantially equal to) the outer diameter of the first external seal member 1132, and this pattern may be repeated throughout the set). Thus, a set of outer seal members 1132 can be used to gradually increase the outer size of the seal with each additional outer seal member 113 in the set until the desired seal is achieved.A tool, such as a sleeve, may be provided to press each such outer seal member 1132 into a desired position.

[0176] In some embodiments, one or more external seal members 1132 may be provided, which may be secured to the valve system 100 when the valve system 100 is implanted as described above, but may be secured from the proximal end of the valve system 100 and pulled or pushed into place from its distal end using a tool (which may be a hook tool). In some embodiments, instead of one or more such external seal members 113, a similar effect may be achieved by inserting (after implantation) one or more annular members 1133 (see, e.g., FIG. 17 ) into the catheter 16 at its end (i.e., the proximal end) adjacent the retention mechanism. Such annular members 1133 may allow fluid flow therethrough, but may also push the walls of the catheter 16 outward to provide a ribbed bulge on its outer surface. Members other than annular members 1133 may be used for this purpose, for example, a cage member (e.g., a mesh sphere) may be used.

[0177] In some embodiments, the or each external seal member 113 may include a sleeve member 1134. The sleeve member 1134 may be configured to be disposed around at least a portion of the valve system 100 and may be secured thereto (e.g., with an interference fit and / or adhesive). The sleeve member 1134 may extend along at least a portion of the length of the valve system 100. In some embodiments, the sleeve member 1134 may extend between two other forms of external seal members 113 (such as those described herein). Multiple sleeve members 1134 may be provided. The or each sleeve member 1134 may include one or more regions 1134a on its outer surface that are of a different material and / or texture than one or more other regions. In some embodiments, the or each sleeve member 1134 may include one or more holes therethrough such that the or each sleeve member 1134 is a perforated sleeve member 1134. The or each sleeve member 1134 may be configured to reduce the risk of adhesion between the urethral wall and the valve system 100. The or each hole or area of ​​different material / texture 1134a may be provided in a pattern - this may include circumferential bands like ribs and / or axial lengths like ribs and / or patches or spots (e.g., as shown in FIG. 18).

[0178] One or more components of the valve system 100 may have a larger outer dimension (e.g., diameter) than one or more other components. The larger outer dimension one or more components may be configured to accommodate one or more portions of a patient in which the valve system 100 is implanted. For example, the outer dimension of the valve system 100 passing through the external sphincter 24 may be larger (with respect to the normal direction of fluid flow) than the top of the external sphincter 24. The larger outer diameter may be provided in the catheter 16 and / or the valve 1 and / or one or more external seal members 113 as described herein.

[0179] In some embodiments, the outlet port 25 of the valve 1 may be at least partially defined by a tapered end (see, e.g., FIG. 19)—which may be the end of the valve body 11 or a plug that defines the outlet port 25. This may help reduce the risk of blockage of the outlet port 25 and / or ingrowth into the valve 1.

[0180] In some embodiments, an insertion tool 300 is provided that has a different form than that described above with respect to the prior art or with respect to the embodiment described with reference to Figures 11 and 12. Examples of insertion tools 300 are shown in Figures 20a-20l.

[0181] The insertion tool 300 may include a body 301 that is at least as stiff as the valve system 100. The body 301 may be sufficiently stiff to allow the body 301 to push the valve system 100 into a desired implantation location. The body 301 may be generally elongated (to fit through the human urethra). In some embodiments, the stiffness of the body 302 may vary along its length to provide one or more portions that are stiffer than other portions (this may be achieved by a variation in cross-sectional size and / or shape along portions of the body 301). At the proximal end of the body 301 is a valve system mounting member 302. The valve system mounting member 302 is configured to engage at least a portion of the valve system 100, which may be the valve 1. In some embodiments, the valve system mounting member 302 is configured to engage the valve 1 at the outlet port 25 and may (when engaged) extend at least partially into the outlet port 25 or around a portion of the exterior surface of the valve 1.

[0182] The engagement of the valve system mounting members 302 is such that the valve system 100 can be pushed by the insertion tool 300 during implantation, and also such that the valve system 100 can be pulled somewhat in the opposite direction.

[0183] The valve system mounting member 302 can take a number of different forms.

[0184] In some embodiments (see, for example, FIG. 20d or 20c), the valve system mounting member 302 may include a hook (which may be a barbed hook) configured to engage with the material of the valve body 11 and / or a plug disposed toward the outlet port 25. FIG. 20l shows a variation of the hook embodiment, which may be cone-shaped. The valve system mounting member 302 may pass through the outlet port 25 into the interior valve volume 111 and engage an internal component thereof, such as a valve seat or a portion thereof.

[0185] In some embodiments (see, e.g., FIG. 20f), the valve system mounting member 302 may include a helical thread (and the mounting member 302 may be tapered) configured to engage with the material of the valve body 11 and / or a plug disposed toward the outlet port 25. FIG. 20h, for example, is a variation of the embodiment of FIG. 20f. In this embodiment, the valve system mounting member 302 may be in the form of a helically wound wire. The helically wound wire may be configured to engage with the material of the valve body 11 and / or may pass through the outlet port 25 by its rotation.

[0186] In some embodiments (see, e.g., FIG. 20d), the valve system mounting member 302 may include a hinge hook (which may be a barbed hinge hook) that is configured to engage with the material of the valve body 11 and / or a plug positioned toward the exit port 25, but is also configured to rotate upon release to lie along the longitudinal axis of the body of the insertion tool (to aid in extracting the tool without damaging the urethral wall).

[0187] In some embodiments (see, e.g., FIG. 20e), the valve system mounting member 302 may include a magnetic engagement member configured to engage the valve element 14 and / or the ferromagnetic ring 5 via magnetic attraction (for which the magnetic engagement member may extend into the valve 1, e.g., through the outlet port 25). FIG. 20g, for example, illustrates a variation of the embodiment of FIG. 20e. In this embodiment, the magnetic engagement member may be shaped to pass, at least in part, through the outlet port 25. Thus, the magnetic engagement member may include a cylindrical portion shaped and dimensioned to be at least partially received by the outlet port 25.

[0188] In some embodiments (see, e.g., FIG. 20b), the valve system attachment member 302 may include a deployable member (which may include one or more arms, loops, or rings) configured to be deployed within the internal valve volume 111, preventing the deployable member from being removed through the outlet - the valve system attachment member 302 extends through the outlet 25 to the valve 1. The deployable member may be selectively actuable to a non-deployed state - to achieve this, the deployable member may be coupled to a wire that extends through the body 301 of the insertion tool to its distal end, such that pulling on the wire causes the deployable member to at least partially retract into the valve system attachment member 302 and / or the body 302 of the insertion tool 300 (both of which may be at least partially in tubular form). The deployable member 302 may include, for example, one or more resilient members.

[0189] FIG. 20i illustrates yet another exemplary embodiment in which the valve system mounting member 302 includes one or more deployable members. Specifically, the valve system mounting member 302 may include one or more deployable wings (two are shown). The or each wing may be arranged to extend radially outward from the longitudinal axis of the insertion tool 300 in the deployed state (as shown). In the stored state, the or each deployable member (e.g., wings) may be retractable (e.g., to a resting position along the length of the body 301). The or each deployable member may be arranged in the stored state for insertion through the urethra, for example. The or each deployable member may be arranged in the deployed state with the or each deployable member within the internal valve volume 111 (i.e., passing through the valve seat). The or each deployable member may be a hinged member, and actuation may be controlled via one or more cables (which may extend through the body 310). The or each deployable member may have a hook-like configuration, for example as shown in Figure 20k.

[0190] In some embodiments, the or each deployable member may be configured to assume a deployed state upon movement outwardly through exit port 25, for example.

[0191] 20j is a variation of the embodiment of FIG. 20b, in which the deployable member may include an inflatable member, such as a balloon, that is inflatable using an inflation fluid (such as saline), which may be delivered to (and withdrawn from) the inflatable member through body 301. Inflation may occur with the inflatable member within internal valve volume 111.

[0192] In a similar manner, in some embodiments (see, e.g., FIG. 20a), the valve system mounting member 302 may include a retractable loop configured to engage an outer surface of the valve 1, where the loop can be expanded or retracted using a portion of the loop material that extends to the distal end of the insertion tool 300 (e.g., through a portion of the insertion tool 300).

[0193] As will be appreciated, the valve system mounting member 302 may be configured in a deployed state having a first diameter and a stored state having a second diameter - the first diameter being greater than the second diameter. For example, the deployed state may be used to engage the valve 1 and the stored state may be used to insert the tool 300 into the urethra.

[0194] As will be appreciated, the distal end of the tool 300 can be manually manipulated to insert or extract the valve system 100 .

[0195] The insertion tool 300 described above may be used as an extraction tool 300 or may be a combination insertion and extraction tool 300 .

[0196] In some embodiments, the elastomer described herein may be silicone. Silicone may be used to form the valve body 11, and / or the valve seat 4 and / or the valve seat member 41.

[0197] In some embodiments, other elastomeric polymers may be used.

[0198] Valve 1 and / or other portions of valve system 100 may be coated with an antibacterial and / or antifungal and / or lubricious material. This may be accomplished by external seal member 113 or in other ways (e.g., in addition to external seal member 113) as described herein. As will be appreciated, catheter 16 may be coated with an antibacterial and / or antifungal and / or lubricious material. For example, the outer surface of catheter 16 - which may be substantially the entire outer surface - may be so coated. In some embodiments, the inner surface of catheter 16 is also (or alternatively) so coated. Thus, in some embodiments, substantially the entire catheter 16 may be coated in this manner.

[0199] In some embodiments, the valve body 11 can be combined with tubular plugs at the inlet 112a and / or outlet 25a to form a valve body configuration.

[0200] As used in this specification and claims, the terms "comprises" and "comprises" and variations thereof mean that the specified features, steps or integers are included. These terms are not to be interpreted as excluding the presence of other features, steps or components.

[0201] The features disclosed in the foregoing description, or the following claims, or the accompanying drawings, whether expressed in a particular form, or in terms of means for performing a disclosed function, or a method or process for achieving a disclosed result, may, as appropriate, be utilized to realize the invention in various of its forms, either separately or in any combination of such features.

Claims

[Claim 1] 1. An intraurethral magnetic valve having an inlet port and an outlet port, said valve comprising: A valve body; a ferromagnetic ring disposed at least partially within the valve body; A valve seat; a magnetic valve element disposed within an interior volume defined by the valve body and configured to move relative to the ferromagnetic ring; wherein the movement is within the valve body between a closed configuration that prevents fluid from flowing from an inlet port through an outlet port and an open configuration that allows fluid to flow from the inlet port through the outlet port, the movement of the magnetic valve element is exposed to a magnetic field from an external magnetic member, and the valve seat is formed from an elastomeric material.

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